LKC TECHNOLOGIES UTAS User manual

Rx only
Part No. 96-020-EN
UTAS
System Hardware
User’s Manual
Issue Date: 2023-02-13
2797

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EN - http://www.lkc.com/IFUsPrintable instructions for use (IFU) in multiple languages are
stored on the UTAS computer as PDF files in the IFU folder on the computer desktop screen,
or go to www.lkc.com/IFUs
DE - Druckbare Nutzungsanweisungen (IFU) in mehreren Sprachen werden auf dem UTAS-
Computer als PDF-Dateien im IFU Ordner auf Ihrem Desktop gespeichert. Alternativ können
Sie www.lkc.com/IFUs besuchen.
ES - En el ordenador UTAS hay almacenadas como archivos PDF instrucciones imprimibles de
uso en varios idiomas, en la carpeta IFU del escritorio del ordenador, o acceda a
www.lkc.com/IFUs
FR - Des instructions d'utilisation à imprimer (IFU) dans plusieurs langues sont stockées sur
l'ordinateur UTAS sous forme de fichiers PDF dans le dossier IFU présent sur le bureau. Vous
pouvez également les obtenir sur www.lkc.com/IFUs
IT - Le istruzioni per l'uso stampabili (IFU) in più lingue sono archiviate sul computer UTAS
come file PDF nella cartella IFU sul desktop. In alternativa, sono reperibili all'indirizzo
www.lkc.com/IFUs
PL - Instrukcje obsługi (IFU) do druku w wielu językach przechowywane są na komputerze
UTAS jako pliki PDF w folderze IFU na pulpicie komputera lub na stronie www.lkc.com/IFUs

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European regulatory data
Basic UDI-DI (for EUDAMED database searches) – 0857901006UTAS79
Instructions for use (IFUs) in other languages may be found at www.lkc.com/IFUs
To request a printed copy of this manual please send an email to [email protected] and
include the following information:
1) Company name
2) Your Name
3) Mailing address
4) The Serial Number of your device
5) The part number of the manual you need
To find the correct part number, open the pdf file in the IFU in the language you
want and find the part number, the part number will appear on either the front or
back of the IFU. The manual part number will look something like 96-123-AB.
Your manual will be shipped to you within 7 days.

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LKC Technologies, Inc.
2 Professional Drive Suite 222
Gaithersburg, MD 20879
USA
301.840.1992
800.638.7055
301.330.2237 (fax)
[email protected]
www.LKC.com
Copyright © 2008 – 2023, LKC Technologies Inc., All Rights Reserved
WARRANTY
LKC Technologies, Inc. unconditionally warrants this instrument to be free from defects in
materials and workmanship, provided there is no evidence of abuse or attempted repairs
without authorization from LKC Technologies, Inc. This Warranty is binding for one year from
date of installation and is limited to: servicing and/or replacing any instrument, or part
thereof, returned to the factory for that purpose with transportation charges prepaid and
which are found to be defective. This Warranty is made expressly in lieu of all other liabilities
and obligations on the part of LKC Technologies, Inc.
DAMAGE UPON ARRIVAL
Each instrument leaves our plant, after rigorous tests, in perfect operating condition. The
instrument may receive rough handling and damage in transit. The shipment is insured
against such damage. The Buyer must immediately report, in writing, any concealed or
apparent damage to the last carrier as well as to us and issue an order for replacement or
repair.
DEFECTS OCCURRING WITHIN WARRANTY PERIOD. Parts of the units may develop defects
which no amount of initial testing would have revealed. The price of our instruments makes
provision for such service, but it does not:
1. Provide for transportation charges to our factory for service,
2. Provide for services not performed or authorized by us,
3. Provide for the cost of repairing instruments that have obviously been abused or
subjected to unusual environments for which they have not been designed.
We will be happy at any time to discuss by phone, letter, FAX, or e-mail suspected defects or
aspects of instrument operation that may be unclear. We advise you to inform us by phone,
letter, FAX, or e-mail of the nature of the defect before returning an instrument for repair.
Many times, a simple suggestion will solve the problem without returning an instrument to
the factory. If we are unable to suggest something that solves the problem, we will advise
you as to what parts of the equipment should be returned to the factory for service.

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DEFECTS OCCURRING AFTER WARRANTY PERIOD. Charges for repairs after the warranty
period and within LKC product lifetime policy will be based upon actual hours spent on the
repair at the prevailing rate, plus cost of parts required and transportation charges; or you
may elect to purchase an extended warranty.
We will be happy to discuss by phone, letter, FAX, or e-mail any problem you may be
experiencing.
LKC PRODUCT LIFETIME POLICY
The lifetime of a UTAS system is 7 years from the original shipment date of the UTAS
system. LKC will service any UTAS system that is within its lifetime.
DISPOSAL
Follow all local and national regulations regarding proper disposal.
Single use electrodes and reusable electrodes at the end of their usefulness should be
disposed of in accordance with local guidelines (typically as medical waste).
The UTAS system at the end of its life should be disposed of as electronic waste.
SOFTWARE LICENSE
The UTAS software is a copyrighted product of LKC Technologies, Inc. and is included with the
UTAS system under the following license agreement:
The software may be used in conjunction with the UTAS system only. The purchaser of the
UTAS system may make copies of the software for convenience of use, provided the LKC
copyright notice is preserved with each copy. This license specifically prohibits the use of this
software in a system that does not include an LKC Technologies, Inc. UTAS Interface Unit.
Additional copies of the software may be purchased to produce reports of UTAS data using a
stand-alone computer system.

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1Introduction................................................................................................................ 9
1.1 Intended Purpose and Intended Users.....................................................................9
1.2 Contraindications .....................................................................................................9
1.3 Product Performance .............................................................................................10
1.4 Essential Performance............................................................................................10
1.5 Precautions ............................................................................................................10
1.6 Electromagnetic compatibility (EMC).....................................................................12
1.7 Warnings and Symbols ...........................................................................................15
1.8 Approvals ...............................................................................................................16
1.9 Environmental........................................................................................................17
1.9.1 RoHS Compliance ...........................................................................................17
1.9.2 China RoHS2 Compliance ...............................................................................17
1.9.3 WEEE Compliance...........................................................................................17
1.9.4 UTAS Packaging ..............................................................................................17
1.9.5 California Proposition 65 ................................................................................19
1.10European Representative.......................................................................................19
1.11 Swiss Representative..............................................................................................19
1.12 Reporting of serious incidents................................................................................20
2Functional Description/ Technical Specifications ...................................................... 20
2.1 UTAS System Specifications .........................................................................................20
2.1.1 Sunburst Ganzfeld Stimulator.........................................................................20
2.1.2 Bigshot Ganzfeld Stimulator ...........................................................................21
2.1.3 Pattern Stimulator..........................................................................................21
2.1.4 Amplifier Unit .................................................................................................21
2.1.5 Utas Interface Unit .........................................................................................22
2.1.6 UTAS System ..................................................................................................22
2.2 System Interface ....................................................................................................23
2.3 UBA Patient Amplifier ............................................................................................23
2.3.1 UBA System Connections ...............................................................................23
2.3.2 UBA Power .....................................................................................................23
2.3.3 UBA Inputs......................................................................................................24
2.3.4 UBA Positioning..............................................................................................24
2.4 Ganzfeld .................................................................................................................25

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2.4.1 SunBurst .........................................................................................................25
2.4.2 BigShot ...........................................................................................................26
2.5 Pattern Monitor .....................................................................................................26
2.6 Overall Equipment Interrelations ...........................................................................27
3Setting Up the System .............................................................................................. 29
3.1 Inventory................................................................................................................29
3.1.1 Operator's Station on workstation .................................................................29
1.12.1 Instrument/Patient's Station ..........................................................................29
3.2 Precautions ............................................................................................................30
3.2.1 Power Main Interference ...............................................................................30
3.2.2 High Frequency Electrical Noise .....................................................................30
3.2.3 Shielding.........................................................................................................30
3.3 Equipment Interconnections..................................................................................30
4System Maintenance & Calibration........................................................................... 32
4.1 Computer Backup...................................................................................................32
4.2 Calibration..............................................................................................................33
4.3 Maintenance and Cleaning.....................................................................................33
5Checking the system ................................................................................................. 33
5.1 Checking the UBA (Amplifier) Response.................................................................33
5.2 Checking Ganzfeld Calibration................................................................................35
5.2.1 Overview ........................................................................................................35
5.2.2 Checking Calibration Using Zenith Software (for SunBurst Only) ...................36
5.2.3 Checking Calibration on Your Own .................................................................38
6External Triggers (Input and Output) ........................................................................ 38
6.1 Triggering External Equipment – Trigger Out .........................................................39
6.2 Receiving Triggers from External Equipment – Trigger In.......................................39
7Cleaning and Disinfection ......................................................................................... 39
7.1 Cleaning the ganzfeld .............................................................................................39
7.2 Cleaning the exterior..............................................................................................40
8Sterilization .............................................................................................................. 40
Appendix 1: LKC Accessory Electrode and Supplies List.................................... 41
Appendix 2: Artifacts in Electrophysiological Testing .......................................... 42

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1Introduction
The UTAS is an electrophysiology system used in the diagnosis of disorders affecting the retina
and optic nerve. The principal hardware components are visual stimulators, response
recording equipment, and a controlling computer with the necessary software to control the
stimulator, collect and analyze the data, and display testing results. Stimulator options
include full-field ganzfelds and pattern monitors. The response recording options include a
UBA amplifier to measure electrical responses and a push-button to record psychophysical
responses. Hardware and software options enable testing, for example, the
electroretinogram (full-field, pattern, multifocal), visual evoked response (also called visual
evoked potentials (VEP)) (full-field, pattern, multifocal), electro-oculogram (EOG), and dark
adaptation. These tests are considered the principles of operation of the device and details
for performing the tests are detailed in the applicable Software Manuals. The UTAS is a fully
automated system providing features needed for both clinical and research applications. The
UTAS meets all the specifications and requirements of the International Society for the Clinical
Electrophysiology of Vision (ISCEV). UTAS is the trade name for this device and all associated
components including software.
This manual explains how the system is connected, the specifications for the system, how to
use the hardware features, and how to assist LKC in servicing the system should trouble arise.
It also covers the UTAS hardware including information on system configuration, set-up,
calibration, electrical and environmental safety, and other important regulatory information
pertaining to the use of the UTAS. Separate software manuals cover the use of the individual
software including explicit instruction on testing patients. It is important to be familiar with
the hardware manual and the software manual(s) before you test patients. Supporting
software manuals include:
-96-034 UTAS ECLIPSE Dark Adaptometry User’s Manual
-96-022 UTAS EMWin Software User’s Manual
-96-014- UTAS Multifocal Software User’s Manual
1.1 Intended Purpose and Intended Users
The UTAS Visual Electrodiagnostic Testing System is an electrophysiology system used in the
diagnosis of disorders of the retina and visual pathway.
This equipment is offered for sale only to qualified Health Professionals.
The intended users of the device are intended to be physicians, optometrists, medical
technicians, clinical medical assistants, nurses, and other health-care professionals.
Operator training is provided by LKC upon installation of the UTAS, training is typically 2 or 3
days depending on the system configuration upon user request. This training, along with this
User’s Manual, should be adequate. Periodic retraining is not necessary; however, if
retraining is desired please contact LKC.
1.2 Contraindications
• Do not use with patients diagnosed with photosensitive epilepsy.
• Do not use Sensor Strips with patients who are allergic to the Sensor Strip gel.

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• Avoid use when the orbit structure is damaged or surrounding soft tissue has an open
lesion.
Some patients may feel discomfort when viewing the flickering light that the UTAS creates to
test their eyes. This discomfort usually subsides quickly when the test procedure completes.
1.3 Product Performance
The UTAS’s normal operation includes measuring flicker implicit time with a single-patient,
single-day standard deviation that is typically less than or equal to 1.0 ms; therefore, the UTAS
must operate with no unintended deviations in settings and with typical operation.
Contact your distributor or LKC if changes in performance are noted.
1.4 Essential Performance
The UTAS is neither life supporting nor life sustaining nor is it a primary diagnostic device; its
function is to aid a physician in making a diagnosis in combination with other data and in light
of the physician’s knowledge and experience, as such the UTAS has no Essential Performance
as pertains to risk.
1.5 Precautions
•The UTAS is designed for depot service; servicing of this equipment is to be performed
at LKC Technologies, Inc. or at a service center approved by LKC Technologies, Inc.
•Only equipment supplied by LKC Technologies, Inc. should be plugged into the outlets
at the back of the UTAS Interface component.
•The UTAS system needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this User’s Manual.
•Portable and mobile RF communications equipment can affect UTAS performance.
•Input overload can occur with defibrillator or electrocautery if used in the operating
room.
•Do not connect the patient to a high frequency (HF) surgical equipment
simultaneously with the UTAS, as it may result in burns at the site of the electrodes
and may damage the UTAS
•Operation of the UTAS in close proximity to a shortwave or microwave therapy
equipment may produce instability in the UTAS recordings.
•Any device connected to this system must be explicitly approved by LKC Technologies,
Inc. and must meet the relevant requirements of IEC 60601-1.
•The use of any accessories or replacement of components other than those supplied
by or approved by LKC Technologies, Inc. may compromise patient safety.
•Eye infections may result from use of non-sterilized contact-lens electrodes.
•The forehead rest should be cleaned and disinfected after each patient.
•This device is not protected against the ingress of water and should not be used in the
presence of liquids which may enter the device.